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Harvard University’s ‘onco-mouse’ can be patented in Europe, the Euro
pean Patent Office decided last week. The EPO had previously rejected the
idea of patents on animals, and its change of heart paves the way for a
flood of biotechnology patents in Europe.

In 1989, the EPO turned down Harvard’s application to patent the mouse,
which had been made susceptible to tumours by inserting an oncogene into
it at the embryo stage. The mouse is patented in the US. The EPO argued
that the European Patent Convention of 1962 prohibits the patenting of animal
varieties.

The biotechnology industry protested that without patent protection,
companies working with transgenic animals would be forced to do their research
outside Europe. The owner of the mouse developed at Harvard, the American
chemicals company Du Pont, appealed against the decision. Last year the
appeals board of the EPO told its patent examiners to reconsider.

The appeals board said the onco-mouse was not an animal variety, but
something created using a microbiological process, a category of invention
which is patentable under the European convention. The board said the crucial
question was whether the onco-mouse was a ‘threat to public morality’, which
would make it unpatentable. This, they said, meant deciding whether animal
suffering or environmental threat caused by the invention outweighed its
medical benefit.

Last week, the EPO decided that ‘the onco-mouse’s purpose of facilitating
cancer research and treatment was of paramount importance for the welfare
of mankind’, outweighing its drawbacks. They invited Harvard to resubmit
its patent application.

The decision stops far short of allowing patents on any transgenic creature,
however. The EPO stated that its decision ‘relates exclusively to the Harvard
onco mouse’. This means that further patent applications for transgenic
creatures must be examined individually, and transgenic animals will not
be automatically patentable. ‘It remains to be seen whether other (examiners)
reach different conclusions when considering other applications,’ says the
EPO.

The decision is likely to influence the debate over a proposed European
Community directive on patenting life forms. The directive will provide
guidelines for the separate national patent offices and the EPO on what
they may or may not patent.

The European Parliament is likely to vote for substantial changes to
the directive next week. Last month, its agriculture committee rejected
the directive, saying it was being rushed through with ‘social, ecological
and ethical aspects . . . deliberately played down as a tiresome afterthought’.

The European Parliament’s criticism, together with the vociferous public
campaign by greens and animal rights groups, is likely to weigh heavily
with the Community’s industry ministers, who must vote on the directive
later this year.

The question which then remains is who judges the cases. The EPO says:
‘New technologies cannot be excluded en bloc from patent protection risks.’
But this leaves patent examiners with the task of assessing the risks, a
role which they say might be better left to society and its elected authorities.

Staff at the EPO are already tired of having to grapple with issues
of public morality. ‘We wish someone would invent a transgenic cat to eat
this transgenic mouse,’ said one exasperated patent officer in Munich last
week. ‘Then we could go back to ordinary work.’